Home Medizin Die Kennzeichnung von Zanubrutinib wird auf das follikuläre Lymphom RR ausgeweitet

Die Kennzeichnung von Zanubrutinib wird auf das follikuläre Lymphom RR ausgeweitet

von NFI Redaktion

The US Food and Drug Administration granted accelerated approval to the Bruton Kinase Inhibitor Zanubrutinib (Brukinsa, BeiGene USA) in combination with Obinutuzumab (Gazyva, Roche) for relapsed or refractory follicular lymphoma after two or more systemic therapies.

This approval was based on the ROSEWOOD study, which included 217 adults with relapsed or refractory follicular lymphoma who were randomized in a 2:1 ratio to receive Obinutuzumab plus Zanubrutinib 160 mg orally twice daily until disease progression or unacceptable toxicity, or Obinutuzumab alone. Participants had an average of three prior lines of treatment and as many as 11.

The overall response rate was 69% with the addition of Zanubrutinib compared to 46% with Obinutuzumab alone (P = .0012). After a median follow-up of 19 months, the median response duration was 14 months with Obinutuzumab alone but was not reached in the combination arm, estimated at 69% at 18 months.

In clinical trials, the most common adverse events with Zanubrutinib were decreased neutrophil counts (51%), decreased platelet counts (41%), upper respiratory tract infections (38%), bleeding (32%), and musculoskeletal pain (31%). Serious side effects occurred in 35% of patients.

The recommended dose of Zanubrutinib is 160 mg orally twice daily or 320 mg orally once daily, until disease progression or unacceptable toxicity occurs.

Previously approved indications for the kinase inhibitor include mantle cell lymphoma, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

According to Drugs.com, 120 80 mg capsules cost $15,874.

M. Alexander Otto is a medical assistant with a master’s degree in medical sciences and a journalism degree from Newhouse. He is an award-winning medical journalist who has worked for several major news agencies before joining Medscape. Alex is also an MIT Knight Science Journalism Fellow. Email: aotto@mdedge.com.

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